Lead Quality Engineer Position

4 days ago


Bray, Wicklow, Ireland Pale Blue Dot®Recruitment Limited Full time
Lead Quality Engineer Position

This role presents an opportunity to step into senior-level responsibilities and contribute to a high-performing regulated environment.

A leading medical device company seeks a skilled Lead Quality Engineer to lead and manage quality-related activities, drive excellence, and ensure compliance with ISO 13485 and regulatory requirements.

Responsibilities:

  1. Manage root cause investigations, developing corrective actions and implementing changes.
  2. Develop, implement, and maintain QMS procedures and policies, ensuring adherence to ISO 13485 and regulatory requirements.
  3. Conduct internal audits, identifying areas for improvement and driving quality enhancements.
  4. Oversee validation activities, ensuring process validations, test method validations, and risk assessments are completed effectively.
  5. Provide technical support for quality-related matters, ensuring compliance and process control.
  6. Collaborate with cross-functional teams to develop and implement quality initiatives.

Requirements:

  • Bachelor's degree in Engineering, Quality, or Life Sciences.
  • 3+ years' experience in a medical device or regulated manufacturing environment.
  • Proven experience with root cause analysis, CAPA management, and failure investigations.
  • Familiarity with quality engineering tools and principles, such as FMEA and SPC.


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